Regulatory Watch - Pharmaceutical Technology

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PharmTech Europe

Regulatory Watch

Quality by Design—Bridging the Gap between Concept and Implementation

April 2, 2014

Pharmaceutical Technology

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

FDA and Manufacturers Seek a More Secure Drug Supply Chain

April 2, 2014

Pharmaceutical Technology

New identifiers and tracking requirements aim to block illegitimate products.

Manufacturers Struggle with Breakthrough Drug Development

March 2, 2014

Pharmaceutical Technology

Accelerated testing and production create challenges in documenting product quality.

European Union Packaging Safety Features Come into Effect

March 2, 2014

Pharmaceutical Technology

Manufacturers are taking measures to comply with new package safety rules.

FDA Focuses on Drug Appearance and Attributes

February 2, 2014

Pharmaceutical Technology

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

Metrics Sought to Ensure Drug Quality

January 2, 2014

Pharmaceutical Technology

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

Opioid Regulation Challenges FDA and Manufacturers

December 2, 2013

Pharmaceutical Technology

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Congress Revises Rules for Drug Compounding and Supply-Chain Security

November 2, 2013

Pharmaceutical Technology

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

European Union Introduces GMPs for Excipients

November 2, 2013

Pharmaceutical Technology

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

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Which of the following business challenge poses the greatest threat to your company?
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13%
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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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